Kornimate/medical-research-clean huggingface dataset:
controlling ecc and terminating bottle-feeding habits among toddlers using a modified oral care package

Conditions: Bottle Feeding; Dental Caries in Children

Summary: this study will evaluate the effectiveness of oral health promotion in the prevention of ecc (early childhood caries) in bottle-fed children. half of the patient will receive oral health promotion which emphasizing more on the benefit of stopping the bottle feeding habit, a free-flow cup and oral hygiene kit which include a toothbrush, toothpaste (1000ppm fluoride). the other half of the patient will receive standard of care oral hygiene promotion and oral hygiene kit which include a toothbrush, toothpaste (1000ppm fluoride)

in malaysia, even though there are decreasing trend in caries prevalence from a survey conduct in 1995 to 2015 (87.1% 1995, 76.2% 2005 and 71.3% 2015) \[nohps 2015\], yet the difference is just 15.8% in a period of 20 years. one of the factors which contribute to the development of ecc in children in prolonged bottle-feeding. many literatures had mentioned association of bottle feeding and ecc however there are no controlled studies done on the effect of bottle feeding and ecc. despite antenatal oral health promotion program done by ministry of health malaysia and incorporation of oral hygiene education and oral hygiene instruction during dental visit, the prevalence of ecc remains high. this study will provide evidence regarding the effectiveness of oral health promotion in preventing early childhood caries by early termination of bottle feeding in toddlers.

Eligibility criteria:
inclusion criteria: * malaysian citizen * child age 12 to 24 months old * child with bottle feeding habit (patients from klinik kesihatan ibu \& anak (kkia)) * having at least 2 upper and 2 lower incisors at the time of recruitment * a child is taken care of predominantly by their mother (housewife) or a single carer (maid/ grandmother) * the parent who can read and write in bahasa melayu * full term baby exclusion criteria: * patient with medical problems * cleft lip or cleft palate or both * patient with a craniofacial anomaly

Keywords: infant health promotion program development
incidence of perioperative hypothermia in adults

Conditions: Hypothermia; Anesthesia; Hypothermia Following Anesthesia

Summary: perioperative hypothermia is associated with many complications, including surgical site infections, delayed wound healing, coagulopathy, prolonged hospital and intensive care unit length of stay. perioperative close monitoring of the body temperature is important, and this is recommended by many clinical practice guidelines. in this study the investigators aimed to detect the incidence of perioperative hypothermia in adult patients in the operating room, and to detect the possible associated risk factors.


Eligibility criteria:
inclusion criteria: * any elective operation * asa i-iii physical status exclusion criteria: * emergency operations * asa iv-v physical status * open heart surgeries

Keywords: hypothermia perioperative intraoperative postoperative
clinical decision support to prevent suicide

Conditions: Suicide, Attempted; Suicidal Ideation

Summary: suicide kills 132 americans every day. the first step of suicide prevention is risk identification and prognostication. researchers like this study team have developed and validated predictive models that use routinely collected electronic health record (ehr) data like past diagnoses and medications to predict future suicide attempt risk. the study team's model based in machine learning is known as the vanderbilt suicide attempt and ideation likelihood (vsail). vsail has been validated prospectively and externally to predict suicide attempt risk with a number needed to screen (nns) of 271 for suicide attempt and 23 for suicidal ideation. nns is the number of people who need to receive a test result to prevent one outcome - lower nns is better. this study will evaluate the effectiveness of a clinical decision support system called vanderbilt safecourse using vsail to prompt a novel best practice advisory (bpa) to prompt face-to-face screening with a validated suicide screening instrument like the columbia suicide severity rating scale (cssrs).

the investigators seek to study if identifying patients at high predicted risk of suicide in clinical settings where suicide risk screening only happens sporadically, if at all, will improve face-to-face screening rates and documentation of suicide risk assessment in their ehrs. the investigators will measure the vsail-prompted bpa's effectiveness in real-world clinical settings to increase rates of face-to-face suicide risk screening. vsail requires only data already collected in routine clinical encounters and is calculated in real- time (seconds) at the start of a clinical visit (inpatient or outpatient) at vumc. vsail does not replace clinical judgment in treating suicidality, but the investigators seek to measure whether vsail increases the rates at which the important problem of suicide is addressed and screened effectively. the investigators seek to compare an active, interruptive intervention, a vsail-prompted bpa pushed to providers, to a passive, non-interruptive visual prompt to determine if 1) cds driven by automated risk modeling improves face-to-face screening rates and 2) whether or not that cds needs to be interruptive or non-interruptive to be effective. in the latter case, effective non-interruptive cds would improve care without worsening "alert fatigue." for equipoise, risk scores for all patients in the study sites would be made available in epic flowsheets for review by providers if they choose to do so. in the first phase, the investigators will pilot this cds in neurology outpatient clinics for six months. if study goals are met, the investigators will scale the cds intervention trial across non-mental health specialty settings at vumc over the following 18 months.

Eligibility criteria:
inclusion criteria: 1. \> 18 years of age 2. a visit in neurology (first phase) or other non-mental health specialty setting at vumc (second phase) exclusion criteria: 1) a cssrs conducted within one week of the visit in another care setting at vumc (recent screening)
adoptive t-cell therapy for resistant viral infections after allogeneic hsct

Conditions: Viral Infection After HSCT

Summary: the aim of the study is to evaluate the adverse events and the efficacy of virus specific t lymphocytes selected in vitro from a family donor to treat some refractory viral infections as adenovirus (adv), ebstein barr virus (ebv), cytomegalovirus (cmv) that developed in young patients (age between 0 and 21 years) after allogeneic hematopoietic cell transplantation (allo-hsct) performed at the transplant clinical unit of the irccs g. gaslini institute (igg).

the rationale for the study is based on the evidence that, despite the progress obtained in the management and prevention of viral infections in the patients who received allo-hsct, some viral infections continue to be severe complications that may occurred before the immune recovery. some of these viral reactivations are not responsive to the first or second line treatment and their treatment may be represent an important issue. the adoptive cellular immunotherapy based on the infusion of virus-specific t lymphocytes represent a valid therapeutic option and the quick access to this cellular therapy is crucial to prevent severe organ complications related to viral infection. in this study, the use of virus-specific t lymphocytes obtained from a seropositive family donor, briefly activated in vitro and immunomagnetically captured by their capacity to secrete ifn-gamma allows to obtain a rapidly usable t-lymphocyte population (both cd4+ and cd8+) potentially able to expand into the patient. the effectiveness, safety (peptides used are synthetic, no animal components, closed system production), good tolerance and speed of modality (less than 36 hours for production) is reported by many clinical studies.

Eligibility criteria:
inclusion criteria: * allogeneic transplant with any cells source and conditioning regimen * age between 0-21 years * viral infection/reactivation (cmv, ebv, adv) * resistance of viral infections to treatments * absence of concomitant severe uncontrolled infections * life expectancy exceeding 30 days * absence of acute or chronic uncontrolled graft versus host disease (gvhd) * absence of acute kidney damage (creatinine value\> 3 times the value normal with respect to age) not related to viral infection; * absence of severe acute liver injury (direct bilirubin\> 3mg / dl or glutamic-oxaloacetic transaminase -sgot\> 500 ui/l) not related to viral infection; * presence of informed consent to the treatment of the patient / parent /legal guardian. exclusion criteria: * absence of a suitable donor (seronegativity for the virus in question and / or failure to respond to the secretion test) * patient with severe renal and/or hepatic impairment as specified above * primary or secondary graft failure * relapse of malignant underlying disease

Keywords: cmv adenovirus ebv adoptive t cell therapy allogeneic hematopoietic stem cell transplantation
impact of a nocturnal pressure controlled ventilation on mechanical ventilation weaning duration in patients with chronic obstructive respiratory diseases

Conditions: Noctural Ventilatory Mode and Weaning Duration

Summary: the weaning of mechanical ventilation is difficult period. this period is particularly difficult for patient with obstructive chronic respiratory disease and a long mechanical ventilation is associated with an increased risk of infectious complication, cardiac dysfunction, muscular weakness or barotromatism. no guideline is available on the ventilator mode to use during the night. in weaning period, some studies have demonstrated that nocturnal control ventilation during the weaning period improved the quality and the quantity of sleep. the hypothesis is that use of nocturnal controlled mechanical ventilation could decrease the weaning period duration and the ventilation weaning failure because of a sleep improvement. the main objective is to compare mechanical ventilation weaning period duration according to the nocturnal ventilator mode (pressure controlled ventilation versus pressure support ventilation) in patients with an obstructive respiratory disease. a secondary objective is to evaluate the rate of weaning failure after the first extubation according to the nocturnal ventilator mode and to evaluate the sleep during the weaning period according to the nocturnal ventilator mode.

all patients with weaning criteria, spontaneous breathing test will be done. if patient is able to have spontaneous ventilation with maximum of 16 cm of h2o of pressure support, he could be included in the study. the nocturnal ventilation mode will be randomised between pressure controlled ventilation and pressure support ventilation with the same pressure support than during the day. we will follow the quality and quantity of sleep with continue polysomnography. indeed, patients in icu could sleep during the night but too during the day. we will compare the duration of the weaning period between the two arms.

Eligibility criteria:
inclusion criteria : * patient with invasive mechanical ventilation (with b840 ventilator) * patient with ventilation weaning criteria * patient able to support during the day pressure support ventilation with pressure support lower than 19 cm of h2o. * patient with all mechanical ventilation weaning criteria for the first trial of spontaneous ventilation. * age \> 18 years exclusion criteria : * patient with central apnoea syndrome * patient with narcolepsy * patient with metabolic encephalopathy.

Keywords: pressure support ventilation pressure control ventilation sleep, weaning chronic obstructive respiratory disease weaning duration period
safety and efficacy study of brimochol™, brimochol™ f, and carbachol in subjects with emmetropic phakic and pseudophakic presbyopia

Conditions: Presbyopia

Summary: safety and efficacy study of brimochol™ vs. brimochol™ f vs. carbachol monotherapy topical ophthalmic solutions in subjects with emmetropic phakic and pseudophakic presbyopia

a 3-dose, multicenter, randomized, double-masked, crossover phase 2 safety and efficacy study of brimochol™ topical ophthalmic solution vs. brimochol™ f topical ophthalmic solution vs. monotherapy with carbachol topical ophthalmic solution in subjects with emmetropic phakic and pseudophakic presbyopia

Eligibility criteria:
inclusion criteria: * male or female in good general health * must have presbyopia exclusion criteria: * history of allergic reaction to the study drug or any of its components * any disease or medical condition that, in the opinion of the investigator, would prevent the subject from participating in the study or might confound study results
low level laser in isolated cleft palate repair versus surgical correction without lll in healing process

Conditions: Cleft Palate Children; Laser

Summary: does the use of low level laser (lll) after surgical correction of cleft palate improve healing and decrease incidence of oronasal fistula?

primary objective: to evaluate the effect of adjunctive use of lll after surgical correction of cleft palate in improving healing among children with cleft palate secondary objectives to evaluate the effect of adjunctive use of lll after surgical correction of cleft palate in decreasing incidence of oronasal fistula after surgical repair among children with cleft palate study group: will use lll after surgical correction of cleft palate at day of surgery, 1st day and 3rd day control group: surgical correction of cleft palate without adjunctive use of lll inclusion criteria: 1. age: between 6 to 18 months of age 2. patient has isolated cleft palate exclusion criteria: 1. systemic disease 2. hematological disorder outcome: outcome measure (s) (1ry, 2ry) 1ry: healing assessment 2ry: occurrence of oronasal fistula

Eligibility criteria:
inclusion criteria: 1. age: between 6 to 18 months of age 2. patient has isolated cleft palate exclusion criteria: 1. systemic disease 2. hematological disorder

Keywords: low level laser , cleft palate , healing
an assessment of safe (swift accountable fair enforcement) in cochise county

Conditions: Behavior

Summary: this is a cochise county experiment with innovative probation supervision practices. subjects are assigned to one of three supervision conditions.

historically, rates of failure on routine probation have been high. the result is that large numbers of probationers are ultimately revoked from probation and sentenced to long underlying jail or prison terms. arizona is experimenting with alternatives to routine probation with the goal of reducing the overall burden of incarceration. cochise county in arizona is experimenting with innovative probation supervision practices. subjects are assigned to one of three supervision conditions: probation-as-usual (routine supervision with no deferred jail); discretionary deferred jail in response to probation violations; and arizona's swift, accountable, fair, enforcement, or safe (safe involves non-discretionary deferred jail in response to probation violations).

Eligibility criteria:
inclusion criteria: * supervised on probation in cochise county * residing in cochise county exclusion criteria: * first-time marijuana possession cases

Keywords: behavior drug users criminal justice probation
factor xiii and pulmonary embolism in neurosurgical patients

Conditions: Brain Tumor; Vascular Lesion; Factor XIII Deficiency; Pulmonary Embolism

Summary: two studies (gerlach et al. 2000; gerlach et al. 2002) described the impact of factor xiii on the risk of prospective hemorrhage for patients undergoing craniotomy. since then, factor xiii is measured and substituted in various centers. few reports support the idea of factor xiii being involved in the formation of deep venous thrombosis and pulmonary embolism. in this prospective observational study, patients undergoing craniotomy for brain tumors or vascular lesions are investigated concerning the incidence of postoperative pulmonary embolism in respect of possible risk factors (factor xiii activity levels, standard coagulation parameters, tumor entity, blood loss).


Eligibility criteria:
inclusion criteria: * preoperatively low factor xiii activity * neurosurgical procedure (craniotomy) * substitution of factor xiii * postoperative occurence of pulmonary embolism exclusion criteria:
a multicenter expanded access treatment protocol of lurbinectedin in previously treated sclc in the usa

Conditions: Small Cell Lung Cancer

Summary: this is an expanded access program in the usa to enable eligible patients with previously treated small cell lung cancer to access lurbinectedin treatment prior to fda approval. sites must apply to participate in the program. a medical doctor must assess whether the potential benefit outweighs the risk of the investigational therapy considering the program eligibility criteria and the individual patient's medical history.


Eligibility criteria:
inclusion criteria: * legally competent adult * confirmed and unresectable small cell lung cancer (sclc) * patients must have received one prior chemotherapy containing line * adequate organ, hematological, kidney, metabolic and liver function * recovery from toxicities related to previous treatment(s) * pregnancy must be excluded, medically acceptable contraception method exclusion criteria: * prior treatment with lurbinectedin * certain concomitant diseases/conditions * symptomatic, steroid-requiring or progressive cns involvement. * pregnant or breast-feeding women.
tinnitus rtms 2013

Conditions: Tinnitus

Summary: tinnitus is the perception of sound in the absence of corresponding external sound. tinnitus affects approximately 10-15 % of the population. the prevalence increases with age and it is estimated that more than 20 % of the older people have tinnitus. approximately 10-15 % of tinnitus patients have clinically relevant, disabling tinnitus causing for example anxiety, depression and sleep disturbances. the treatment of chronic tinnitus is difficult and most therapies focus on alleviating the condition rather than treating the cause. pathophysiology of tinnitus still remains incompletely understood. functional brain imaging data in tinnitus patients and animal models suggest that tinnitus is associated with increased neuronal activity, increased synchronicity, and functional reorganization within the auditory cortex either uni- or bilaterally, but there are also functional alterations in brain areas outside the auditory system. transcranial magnetic stimulation (tms) is a neuromodulation technique based on the principle of electromagnetic induction of an electric field in the brain by means of magnetic pulses given to the scalp. tms is a non-invasive, painless, and safe method for modulation of cortical activity. tms pulses given at low frequencies (≤ 1 hz) have been shown to decrease cortical excitability both in experimental settings and humans, which forms the basis for using low frequency rtms to treat chronic tinnitus patients, in whom hyperactivity of the auditory cortex has been observed in functional brain imaging studies


Eligibility criteria:
inclusion criteria: * chronic tinnitus 6 months-10 years * age 18-65 years * tinnitus intensity vas at least 4/10 exclusion criteria: * pulsatile tinnitus * objective tinnitus * epilepsy, brain disease * severe/recent heart disease * pregnancy * alcohol abuse * metallic implants etc.

Keywords: tinnitus transcranial magnetic stimulation
brief hospitalization for schizophrenia: strategies to improve treatment outcome

Conditions: Schizophrenia; Schizophrenic Disorder

Summary: the goal of this research program is to implement a series of psychoeducational training classes designed to teach individuals with schizophrenia the importance of medication treatment, how to identify and manage medication side effects, and how to make appointments and emergency plans. the skills taught to the research subjects will lead to demonstrable increases (compared to the control group) in adherence to both the prescribed medication regimen and scheduled outpatient appointments and thereby cause a decrease (again compared to the control group) in rehospitalization rates and bed-days during subsequent twelve months following the intervention. a secondary objective of this work is that if the crep program is successful and/or illness education is effective, the data will be able to disseminated throughout the visn 22 via the recently awarded mental illness research education and clinical center (mirecc) program.


Eligibility criteria:
inclusion criteria: 1. age 18-65 years of age. 2. dsm iv diagnosis of schizophrenia or schizoaffective disorder. 3. competent to give informed consent. 4. previously participated in "brief hospitalization for schizophrenia: strategies to improve treatment outcome" principal investigator. donna wirshing, m.d. exclusion criteria: 1. physical or cognitive impairment of such severity as to adversely affect the validity of clinical ratings or impair capacity to give informed consent. 2. history of substantial substance dependence 6 months prior to the study. 3. patients at high risk of suicide or other directed violence.
comparison of the effect of nn5401 with the effect of nn1250 and insulin aspart in type 1 diabetics

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this clinical trial is to compare the blood glucose lowering effect of nn5401(insulin degludec/insulin aspart (idegasp)) with nn1250 (insulin degludec (ideg)) and insulin aspart (iasp) in subjects with type 1 diabetes where the trial participant will receive one single dose of each trial product in varying order.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index 18.0-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day). * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period